The Clinical Research (CR) Auditor actively participates in and supports the daily operations of MSKs centralized Clinical Research Audit Program. The incumbent is a participating member of the CR Audit Team. You will: - Conduct all types of audits (protocol compliance, CR database systems, etc.), as dictated by QA Leadership.
- Execute audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP).
- Perform required number of audits each month, supporting team members with audits, as needed.
- Work with QA Leadership to provide feedback, deficiencies and common trends identified in audits to ensure timely and effective change control to improve overall quality.
- Collaborate with Principal Investigators (PIs) and Research Teams on addressing audit findings and developing corrective action and preventive action (CAPA) plans.
- Serve as the Clinical Research Quality Assurance (CRQA) liaison between external auditors/inspectors and MSK PIs/Research Teams during external audits and inspections, serving as the subject matter expert (SME) on federal regulations, ICH GCP and institutional policies.
You need: - Bachelors degree with at least 5 years of clinical research experience or equivalent experience.
- 2 years of management experience.
- Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
- Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all members of MSK; responsible for the writing, preparing and educating staff on clinical research procedures and processes. Individual must be able to communicate effectively with all levels of staff including clinical staff (investigators, nurses, etc.), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors/auditors and regulatory agencies. Excellent oral and written communication skills are required.
- Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
- Information Management Skills: The ability to communicate, explain, interpret, share and present information to MSK employees, including management, and clinical staff, and patients at MSK as well as appropriate external contacts.
- Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability. Ability to analyze situations, draws conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
- Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines. Ability to manage multiple large-scale development projects simultaneously. Ability to guide staff to ensure programmatic activities adhere to established time frames and deadlines.
- Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
- Computer Skills: Proficiency in use of computers and software such as database management, spreadsheet, word processing and graphics applications. Knowledge of mainframe systems utilized at MSK is essential.
Benefits Competitive compensation packages | Sick Time |Generous Vacation+ 12 holidays to recharge & refuel| Internal Career Mobility & Performance Consulting | Medical, Dental, Vision, FSA & Dependent Care|403b Retirement Savings Plan Match|Tuition Reimbursement |Parental Leave & Adoption Assistance |Commuter Spending Account |Fitness Discounts &Wellness Program | Resource Networks| Life Insurance & Disability | Remote Flexibility We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. Its important to us that you have a sense of impact, community, and work/life balance to be and feel your best. Our Hiring Process You review the posting, agree it sounds like a great fit & apply ->Talent Acquisition contacts you to schedule a phone interview (if your profile aligns) -> after speaking with the Talent Acquisition Specialist, you will connect with the Hiring Manager by phone or video -> if your experience is a fit, you will move forward to a video call or on-site visit with the team -> post-interview feedback->ideally an offer! ->reference check & onboarding-> orientation & official welcome to MSK. #LI-POST |
